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Abstract：
BACKGROUND: The purpose of this study was to evaluate whether bone mineral density (BMD) ≥ -2.5 SD could be used as the treat-to-target (T2T) goal when treating osteoporosis with teriparatide (TPTD) and alendronate (ALN), and to investigate the relationship with incident vertebral fracture by re-analyzing data from a randomized, controlled trial (JOINT-05) involving postmenopausal Japanese women at high fracture risk.
METHODS: Participants received sequential therapy with once-weekly TPTD for 72 weeks, followed by ALN for 48 weeks (TPTD-ALN group) or ALN monotherapy for 120 weeks (ALN group). BMDs were measured at the lumbar spine (L2-4), total hip, and femoral neck at 0, 24, 48, 72, and 120 weeks by dual-energy X-ray absorptiometry. The T2T goal was BMD ≥ -2.5 SD, and the endpoint was the proportion of participants with baseline BMD < -2.5 SD in three measurement sites achieving BMD ≥ -2.5 SD.
RESULTS: A total of 559 participants were selected. BMD ≥ -2.5 SD at 120 weeks in the L2-4, total hip, and femoral neck sites was achieved in 20.5%, 23.1%, and 5.9%, respectively, in the TPTD-ALN group and 22.2%, 11.7%, and 7.3%, respectively, in the ALN group. Incident vertebral fractures occurred in areas of both lower and high BMD.
CONCLUSIONS: During the 1.5-year treatment period, more than 20% of participants achieved BMD ≥ -2.5 SD as a T2T goal at L2-4. Since the achievement level differed depending on the BMD measurement site, the appropriate site should be selected according to the baseline BMD level.
METHODS: Participants received sequential therapy with once-weekly TPTD for 72 weeks, followed by ALN for 48 weeks (TPTD-ALN group) or ALN monotherapy for 120 weeks (ALN group). BMDs were measured at the lumbar spine (L2-4), total hip, and femoral neck at 0, 24, 48, 72, and 120 weeks by dual-energy X-ray absorptiometry. The T2T goal was BMD ≥ -2.5 SD, and the endpoint was the proportion of participants with baseline BMD < -2.5 SD in three measurement sites achieving BMD ≥ -2.5 SD.
RESULTS: A total of 559 participants were selected. BMD ≥ -2.5 SD at 120 weeks in the L2-4, total hip, and femoral neck sites was achieved in 20.5%, 23.1%, and 5.9%, respectively, in the TPTD-ALN group and 22.2%, 11.7%, and 7.3%, respectively, in the ALN group. Incident vertebral fractures occurred in areas of both lower and high BMD.
CONCLUSIONS: During the 1.5-year treatment period, more than 20% of participants achieved BMD ≥ -2.5 SD as a T2T goal at L2-4. Since the achievement level differed depending on the BMD measurement site, the appropriate site should be selected according to the baseline BMD level.
摘要：
背景：这项研究的目的是评估在使用特立帕肽（TPTD）和阿仑膦酸盐（ALN）治疗骨质疏松症时，是否可以将骨密度（BMD）≥-2.5SD用作治疗目标（T2T）目标，并通过重新分析来自随机的数据来研究与偶发椎体骨折的关系，对照试验（JOINT-05），涉及绝经后高骨折风险的日本妇女。
方法：参与者接受每周一次TPTD的序贯治疗，持续72周，随后ALN治疗48周（TPTD-ALN组）或ALN单药治疗120周（ALN组）。在腰椎（L2-4）测量BMD，全髋关节,和股骨颈在0、24、48、72和120周通过双能X线吸收法。T2T目标为BMD≥-2.5SD，终点是三个测量部位BMD≥-2.5SD的基线BMD<-2.5SD的参与者比例。
结果：共选择559名参与者。在L2-4，全髋关节，120周时BMD≥-2.5SD，股骨颈部位达到20.5%，23.1%,和5.9%，分别,在TPTD-ALN组中和22.2%，11.7%,和7.3%，分别,在ALN组中。在较低和较高BMD的区域发生了椎体骨折。
结论：在1.5年的治疗期间，超过20%的参与者在L2-4时达到BMD≥-2.5SD作为T2T目标.由于成就水平因BMD测量地点而异，应根据基线BMD水平选择合适的部位。
方法：参与者接受每周一次TPTD的序贯治疗，持续72周，随后ALN治疗48周（TPTD-ALN组）或ALN单药治疗120周（ALN组）。在腰椎（L2-4）测量BMD，全髋关节,和股骨颈在0、24、48、72和120周通过双能X线吸收法。T2T目标为BMD≥-2.5SD，终点是三个测量部位BMD≥-2.5SD的基线BMD<-2.5SD的参与者比例。
结果：共选择559名参与者。在L2-4，全髋关节，120周时BMD≥-2.5SD，股骨颈部位达到20.5%，23.1%,和5.9%，分别,在TPTD-ALN组中和22.2%，11.7%,和7.3%，分别,在ALN组中。在较低和较高BMD的区域发生了椎体骨折。
结论：在1.5年的治疗期间，超过20%的参与者在L2-4时达到BMD≥-2.5SD作为T2T目标.由于成就水平因BMD测量地点而异，应根据基线BMD水平选择合适的部位。
